- Cardinal Health (Augusta, ME)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment IT ... the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- Jabil (Hunt Valley, MD)
- …across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance with ... strategic guidance, technical expertise, and hands-on support throughout the validation lifecycle, including planning, execution, documentation, and audit readiness.… more
- Zimmer Biomet (Austin, TX)
- …regulations and standards: 21 CFR Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity + You have experience with ... this role you will provide leadership and technical direction in software validation , verification, regression testing, and cybersecurity to ensure compliance with … more
- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more
- Kelly Services (Bristol, TN)
- …**LabVantage LIMS** , scheduled for go-live in late February/early March. + Oversee ** computer system validation ** (CSV) for LIMS, Waters Empower (HPLC), SAP ... degree in a scientific, engineering, or related field. + Strong experience in computer system validation and/or process/equipment validation . + Proficiency… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI),… more
- Curia (Albuquerque, NM)
- Validation Analyst II, Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... Validations Department is responsible for formulating, reviewing, and approving all validation protocols related to manufacturing or support operations. The … more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... leads. + Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. +… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …risk assessments, traceability matrices, and validation master plans. + Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to its ... MES, ERP, SCADA, or DCS (eg, Delta V) for computer systems validation engineers. + Advanced knowledge...required. + Familiarity with software development lifecycle (SDLC) and validation tools. + Knowledge of GAMP 5, FDA… more